FDA Postmarketing Study Oversight To Benefit From Informatics Upgrades
Changes in legacy DARRTS system, transition to new platform and standardized format for annual report submission should improve FDA's tracking of postmarketing requirements, agency tells Office of the Inspector General.
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Sponsor representatives also want postmarketing discussions moved to earlier in the assessment cycle.
FDA says compliance is on par with other postmarketing requirements, but jury is still out on whether public posting of noncompliance letters has been effective tool to ensure timely trial completion.
Findings could give pharmacovigilance prominence alongside 'breakthrough' and other speed mechanisms in legislative debate on agency reform.